federal_register: 2019-25328

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2019-25328 Agency Information Collection Activities; Proposed Additional Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications; Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants Notice The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension/revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on "General Licensing Provisions; Section 351(k) Biosimilar Applications; Formal Meetings Between the FDA and Sponsors or Applicants." 2019-11-22 2019 11 https://www.federalregister.gov/documents/2019/11/22/2019-25328/agency-information-collection-activities-proposed-additional-collection-comment-request-general https://www.govinfo.gov/content/pkg/FR-2019-11-22/pdf/2019-25328.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish...

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